This post accompanies a Health Canada Warns post on RxISK.
The Health Canada statement is classic bureaucratise. They
“could not confirm, nor rule out, a causal link between stopping
SSRI or SNRI treatment and persistent sexual dysfunction“
“the available studies were not designed to assess this effect”
Exactly – deliberately designed not to detect. So the bureaucrat sits there until …. Who exactly is going to design and fund and run this study?
And doctors sit there until the bureaucrat stirs. They can both sit for ever – unless perhaps jolted by someone doing something amoral. Defended by their adherence to a bureaucratic morality.
See the correspondence below with Guido Rasi of the European Medicines Agency seven months after EMA agreed to add a warning to drug labels.
January 31, 2020.
Dear Professor Rasi
Responding to a petition sent to you by a large group of clinicians and researchers, in June 2019 EMA indicated they would ask companies to mention enduring sexual dysfunction in the labels of antidepressants.
Many of those affected with PSSD had hoped for more than the very minimal set of words that has resulted. A young Dutch man (22 years old) committed suicide several weeks ago frustrated at the continuing lack of research and hope of a cure. I can send you the details of the website his mother, a doctor, has set up in his honour.
An Italian group of sufferers have been chasing AIFA asking if there is anything more AIFA can do to help. AIFA, as I understand it, have responded that more work is needed, interrogating databases etc to determine if there is a real problem.
While this position might sound reasonable to an outsider, it is neither good for patients with PSSD, nor for perceptions of regulation.
When responding to people with PSSD and the media, I stress that EMA and other regulators do not have a public health function other than checking whether there is support for the wording of claims made for drugs and devices by companies. Few patients understand this. Few take note when regulators mention not wishing to interfere in the relationship between doctors and patients.
On the other hand, regulators appear to stray into the health domain when they talk about licensing treatments on the basis of a risk-benefit analysis, a formulation that leaves many doctors figuring EMA are endorsing taking risks.
I asked Jordi Llinares at a recent meeting about EMA risk benefit analyses and he made it clear these are primarily made on the basis of RCTs.
Clearly EMA license drugs on the basis of RCTs conducted to investigate a primary endpoint – which companies and EMA call “the benefit”. This is 1 of the 100 things a drug does. The extreme focus on one effect, which is the whole point of an RCT, means that the 99 other drug effects are poorly collected, or not noticed, or deliberately ignored.
“The benefit” is what companies want to make money from. In the case of the SSRI “benefit”, there is no evidence for saved lives or restoration of function. Instead rating scale changes allowed regulators let companies advertise “a benefit”, which was less of a “benefit” than the “benefit” provided by an older generation of antidepressants.
This “benefit” is not the commonest thing SSRIs do. Their commonest effect is that they numb genitals of over 90% of takers, within 30 minutes of taking a first pill. Company RCTs looking for a less common but commercially interesting “antidepressant” effect, completely missed this genital effect that should have been unmissable. This almost inevitable effect is still not mentioned in drug labels, 30 years later, even though dapoxetine is licensed for Premature Ejaculation (P.E.) and other SSRIs are used for P.E. on the basis of this effect.
Current labels claim sexual dysfunction was found in less than 5% of people in SSRI trials. Following the logic above, an estimate like this could arise simply as a result of the RCT focus on a primary endpoint which, as mentioned, can lead investigators to miss things that are more common than the primary endpoint. The fact that this can happen upends the standard narrative that RCTs give us the best possible information about drugs, and we can supplement the information they offer with pharmacovigilance input to pick up the rare events or events that happen after lengthy exposure to treatments that RCTs miss.
One consequence of this state of affairs is that while risk-benefit assessments may have a value for companies, they are clinically and scientifically meaningless if RCTs can completely miss the commonest effects of a drug and by implication can miss 90+% of a drug’s other effects – rather than just miss rare effects or effects with a delayed onset..
In the case of the SSRIs and sex, the failure to notice sexual issues was aggravated by companies deliberately not collecting the data. In SSRI healthy volunteer trials, conducted in the 1980s, trials that did not have an extreme focus on a primary endpoint, over 50% of volunteers reported significant sexual difficulties some of which endured after treatment stopped. In later clinical trials, investigators like me were encouraged to think of sexual problems being linked to mood and in some cases were explicitly told not to ask questions about sex. I can give you details of both healthy volunteer and later clinical trials.
Consistent with the healthy volunteer studies, there were reports to regulators by 1991, almost immediately after first marketing of the SSRIs, showing that in some case this sexual dysfunction could endure after treatment – Post SSRI Sexual Dysfunction (PSSD).
The healthy volunteer studies undermine, AIFA. EMA and other regulatory responses that these conditions might stem from the illness rather than treatment. Melancholia, which is very rare, can lead to lowered libido but the kind of depression for which SSRIs are given does not lower libido. Indeed, just like people comfort eat when they have “nerves” so they often have more sex in an attempt to handle their “depression”.
A second clinical feature that undermines EMA’s current position is that in the case of PSSD, patients can rub chilli paste into their genitals and not feel it. If you have any evidence that any psychiatric condition produces an effect like this, I would love to see it.
Between 10-15% of the populations of many European countries now take antidepressants, over 90% of whom are on treatment for over a year with a growing number on treatment for 5 to 10 years or more, primarily because they cannot stop. This difficulty in stopping was another problem noted in the healthy volunteer trials of these drugs in the 1980s – a problem companies have handled for 3 decades by a deceptive use of language and not publishing the data from healthy volunteer trials.
Given that over 10% of the population are on drugs that compromise our ability to make love the way we might wish to, anything up to 20% of us may not in fact be having the sexual relations we might wish to have and would otherwise be able to have. There were articles about this in the popular press featuring prominent people as far back as the last millennium – which again I can send if you wish.
In some Welsh towns the figure for people unable to make love may be closer to 50%. Of some note, perhaps, this is primarily a native European issue – a large presence of immigrant communities will lower the figures, as people from these communities are less likely to be on SSRIs.
Some of those on treatment will live with the hope that once they stop their medicine all will be well when things may be much worse if they develop PSSD. There is in fact no way of knowing how many people have PSSD if the vast majority of people who take these drugs chronically can’t get off them.
This factor might allow EMA to claim that the apparent frequency of PSSD is quite low but making a claim like this would be “economical with the truth” – as the British put it. Claims like this will likely also contribute to further suicides as they give the impression the problem is not important.
Faced with convincing reports of an effect on treatment, companies are under a legal obligation to investigate. They seek access to the patient or the patient’s medical records to see if there is another way to explain the proposed effect. If, in individual cases, they find no other way to explain an effect, they include this effect in the label of the drug under “other reports”. They do not undertake epidemiological or other large database studies before doing so. They establish cause and effect in a way that I and most people can understand rather than turn to ways that both you and I know would support claims that effects have not been proven and further research is needed – ad infinitum.
Many companies have asked me for access to information on the people with PSSD that RxISK has on file. I have not been willing to comply so far as this is a group of people that treatment has rendered vulnerable and an insensitive handling of the matter by companies more interested to defend their drug than to defend patients could lead to further suicides.
As part of the recent petition to EMA, the petitioners included named patient details and records with supportive letters from doctors indicating these patients had been taking an SSRI and the doctor could see no other way to explain the problem other than the effect of the drug. Our hope was that EMA might handle this matter more sensitively.
EMA were told that this material was being sent with patient consent in order to offer EMA a chance to follow up these patients and their doctors in the way companies do. But rather than do this, EMA removed the names of the patients and their contact details.
When asked about this EMA mentioned patient confidentiality, which seems either a case of unthinking bureaucracy or else points to the fact that EMA and other regulators have a very different model for establishing cause and effect to the one companies, doctors and most lay people have.
To return to the risk-benefit issue, companies saw a number of ways they could gain from introducing the idea of risk-benefit into our collective lexicon in the early 1990s. One advantage to companies was letting them argue that if regulators approved a “benefit” based on an RCT, it might be more difficult for regulators to advocate for warnings on medicines – as in the case of the SSRIs and suicide. Warn and regulators could be criticised for deterring people from seeking a benefit that might have saved their lives. This argument seems to have hamstrung regulators, even though the clinical trials show an increase in suicidal events on treatment.
In the case of PSSD, young people are now committing suicide and approaching assisted dying programs because they interpret the lack of a warning to mean that no-one is interested in this problem and no work is being done on finding a remedy. They are correct, in my opinion, to read matters this way. They would likely think EMA/AIFA deeply cynical if they realised, as most insiders like you and I do, that decades of research could be put into databases without coming up with anything useful, least of all a remedy. Some might ask if this delay is what EMA intended.
I recognise that the issues of SSRI antidepressants and sex raise profound issues about what companies and regulators are doing. The matter of what might be done to help patients however is rather straightforward. This is not a matter on which remaining quiet about a hazard will be to the benefit of any current or prospective patients, who might get the benefit without the hazard, in that everyone who takes these drugs will have sexual dysfunction of some sort.
My primary purpose in writing is to support the many people with PSSD, whose hopes were raised by EMA in June, but who now feel their position is little better than it was before June. I would also appreciate hearing your views on the more general regulatory issues questions of Sex and SSRIs raise.
A Rasi-Healy letter follows next week with a final Healy-Rasi letter.
Copyright © Data Based Medicine Americas Ltd.
Hold the front page …
‘Health Canada’s review could not make conclusions about worsening or new symptoms of sexual dysfunction as the available studies were not designed to assess this.’
Example of ‘available studies were not designed to assess this’ – back to front illogical thinking – Emotionally Labile/Lability
“five cases of suicidal thoughts and behaviour were listed as “emotional lability” “
“hidden under the term emotional lability”
GSK backs campaign for disclosure of trial data
One Clear Comment
05 March 2013
Peter C Gotzsche
Nordic Cochrane Centre
At least eight children became suicidal on paroxetine versus one on placebo, but in the published paper, five cases of suicidal thoughts and behaviour were listed as “emotional lability” and three additional cases of suicidal ideation or self-harm were called “hospitalisation.” The abstract of the paper concluded that “Paroxetine is generally well tolerated and effective.” Trial 329 was widely believed and cited (184 times by 2010), and it lured many doctors into using paroxetine for childhood depression, although the drug is harmful. The trial has not been retracted despite repeated calls on the journal to do so.
The Attorney General of New York State sued GSK in 2004 for repeated and persistent consumer fraud in relation to concealing harms of paroxetine, and GSK was required as part of a legal settlement to make the individual patient level data from that trial available, but they didn’t do so.
Only when Dr Peter Doshi contacted the New York Attorney General’s office in 2012 and said that the data weren’t there, did the data get posted. The clinical study report is now available on GSK ‘s home page
Trail Of Paxil Suicides Leads
By Evelyn Pringle
16 February, 2007
The European Medicines Agency (EMEA) alerted the FDA to the suicide risk in mid-2003. Glaxo did not. According to an internal June 2, 2003, FDA email provided to this author by Baum Hedlund, written by Dr Russell Katz to Dr Andrew Mosholder, the FDA had just learned about the increased suicide rate hidden under the term emotional lability and realized that Glaxo had pulled a fast one.
So the bureaucrat sits there until ….
JOFRE: Hang on, rewind a second. Yeah, he really did just stroke me under the chin.
No such naivety there …
Emer Cooke has begun her mandate as Executive Director of the European Medicines Agency today, 16 November 2020.
Ms Cooke was nominated as Executive Director with a renewable five-year mandate by the Agency’s Management Board on 25 June 2020 and is the first woman at the helm of EMA. She was appointed following her statement to the European Parliament’s Committee on Environment, Public Health and Food Safety (ENVI) on 13 July 2020.
As ever the same dodgy types and their clones do the rounds on cttees which wield unaccountable power – in this case across the EU but likely other countries will do the same
Former Executive Director
European Medicines Agency
Prof Guido Rasi served as the Former Executive Director of European Medicines Agency (EMA) until November 2020.
He has been elected Chair of the International Coalition of Medicines Regulatory Authorities (ICMRA) from 1st October 2019 for a term of 3 years.
He was Director-General of the Italian Medicines Agency from 2008 to 2011 and member of the Management Board from 2004GB
AND on youtube
Vaccination certificate may be launched by end-month, EU Vice-President Margaritis Schinas
81 views•19 Jan 2021
EU Debates | eudebates.tv
European Commission Vice-President Margaritis Schinas on Tuesday stressed the benefits of vaccination certificates amid the coronavirus pandemic, saying they are of “utmost importance,” and indicated that such an initiative may be approved by the end of January. https://www.eudebates.tv/debates/eu-p…
His comments came ahead of a meeting of EU leaders on Thursday, in which a proposal made last week by Greek Prime Minister Kyriakos Mitsotakis for a European certificate showing when an individual has been vaccinated against the novel coronavirus will be discussed.
Vaccination certificate may be launched by end-month, EU Vice-President Margaritis Schinas
Smooth operators – on both sides Has EMA really been…….’ (EMA) has been a pioneer of data transparency among regulatory agencies. EMA’s policies on access to documents and proactive publication of CSRs have made extensive clinical trial information publicly available. Still waiting Rasi – oops you’ve moved on – not your responsibility.
from the Instituts for Quality and Efficiency in Health Care
All clinical trial data on Covid-19 medicines and vaccines should be published on the day of marketing authorisation!
Read the open letter to EMA here
PDF,128 kB, PDF
Open letter to the European Medicines Agency
EMA should support the international research community by publishing Clinical Study Reports on medicine and vaccine trials at the time of marketing authorisation
Dear Professor Rasi,
The current 2019 coronavirus disease (COVID-19) pandemic is the greatest health care and economic crisis Europe and many other parts of the world have faced in several decades. As a result, unprecedented research efforts are underway to develop or identify effective medicines and vaccines. Researchers from all over the world have joined forces to identify or develop, test and evaluate medicines and vaccines to fight the pandemic.
Regulatory agencies will have a crucial role in deciding which of these medicines and vaccines will be made available to patients and the public. To support the regulatory decision-making process, regulatory policies require submission of detailed and well-organised evidence packages in the form of Clinical Study Reports (CSRs).
In recent years, the European Medicines Agency (EMA) has been a pioneer of data transparency among regulatory agencies. EMA’s policies on access to documents and proactive publication of CSRs have made extensive clinical trial information publicly available. EMA has defended this transparency before the Court of Justice of the European Union. It is exactly this transparency that is currently needed.
Because of the severity of the current situation, regulators are aiming to accelerate the marketing authorisation process. First treatments have already been evaluated by regulators, as recently seen with the fast emergency use authorisation of the antiviral remdesivir by the US Food and Drug Administration (FDA). EMA has also started a “rolling review” of remdesivir. This acceleration effort is understandable and to be welcomed in this exceptional situation. To achieve sustainable effects in health care, this effort must also include the publication of CSRs to make the full information on any new medicine or vaccine publicly available as soon as possible.
We therefore call for the publication of all CSRs on all COVID-19 medicines and vaccines on the day of marketing authorisation.
The international research community is undertaking coordinated efforts (e.g.the Living mapping and living systematic review of Covid-19 studies) to compile all emerging information on COVID-19 medicines and vaccines to ensure the optimal planning and conduct of research and to inform treatment decisions. To assess these products further and to accelerate the development of additional products, the fast and full public availability of the information submitted to regulators is of utmost importance. Transparency is also vital to maintain public trust during the crisis. With its established processes, EMA is in a unique position to make a difference in the worldwide fight against the pandemic.
Im Mediapark 8
28 May 2020
Dear Dr Wieseler, Dr Kaiser, Prof Dr Boutron, Prof Dr Devane, Prof Dr Gartlehner, Prof Dr Meerpohl and
Prof Dr Ravaud,
Thank you for your letter of 14 May 2020 in support of our activities to increase transparency of
medicines development and regulation.
I concur with you that we face an unprecedented global challenge with this pandemic and that
scientists, researchers, pharmaceutical companies and regulators all have an important role to play.
Close collaboration is essential to mitigate the devastating effects of the disease on our society. By
pooling our efforts and resources we can more effectively advance science and bring to patients and
citizens around the world much needed safe and effective therapies.
I can assure you that the European Medicines Agency and the EU Regulatory Network as a whole is
fully committed to support and facilitate the development of new medicines for COVID-19. We will use
every opportunity to gain efficiencies and speed up our evaluation procedures whilst ensuring that our
high standards on quality, safety and efficacy continue to apply.
I also agree with you that transparency and timely information on COVID-19 related activities is more
relevant than ever for the public in the present circumstances. As you note, the Agency was a pioneer
in this area and has brought unprecedented levels of transparency to medicine development and
regulation by making public the clinical data underpinning EMA’s recommendations soon after the
medicines’ authorisation in the EU.
Our activities in relation to COVID-19 deserve the highest possible level of transparency and, in
keeping with our commitment, the Agency will take appropriate action to share information publicly.
We are currently discussing how to enhance the level of transparency for COVID-19 procedures,
including the possibility of rapidly publishing clinical data for these products. The need for rapid
evaluation during the current emergency will require us to depart from our usual procedures. In some
cases, we will be evaluating evidence as it emerges (i.e. ‘rolling review’) and putting information in the
public domain in these circumstances will be subject to additional challenges which we are currently
looking to address.
As you may be aware, the Agency had to deal with the direct consequences of Brexit and the move
from London to Amsterdam in recent years, involving a huge impact on staffing and other services.
EMA/280976/2020 Page 2/2
Inevitably, this disruption required the Agency to shift all its focus to core activities that are essential
for public health. Regrettably, our efforts to publish clinical data had to be put on hold in these very
In view of this and the extra effort needed to deal with COVID-19 related activities, I can’t yet commit
to reinitiate all activities related to clinical data publishing for medicines evaluated by the Agency.
However, as stated above, COVID-19 related medicines deserve special consideration because of the
overriding public interest and the need to support the international research community and foster the
collaborative effort. Further information on the concrete proposals to increase transparency of COVID19 related activities will be communicated once agreed within EMA and the EU Regulatory Network.
I hope this reassures you of our commitment to transparency, along the lines expressed in your letter
and provides you with some insight on how we plan to apply this to our activities in response to this
unprecedented global challenge.
In a democracy citizens should be able to air all sides of a debate without being demonised …or treated like fools to be educated into ‘rightful thinking’ A vaccine passport is being discussed on the media more often in the last week as a probable in UK – even though the vaccine tzar has stated on BBC that it does not belong in a democracy like UK
Fierce Pharma’s JPM 2021 (It’s Free to subscribe )
Remember normal? Pfizer and BioNTech join with health groups to remind us—and promote COVID-19 vaccine safety
by Sharon Klahr Coey | Jan 21, 2021 10:25am
Pfizer and BioNTech join with health groups to promote “Science can make this possible. Only you can make it real,” COVID-19 awareness campaign.(Getty/Meyer & Meyer)
Remember hugging, playing with grandchildren, kissing people goodbye and sharing exciting news with family in person? While COVID-19 has kiboshed those things, Pfizer and BioNTech want to remind people about them—and how they’ll be possible again with vaccines.
The Comirnaty vaccine makers, together with a coalition of health organizations, recently debuted an awareness campaign aimed at shoring up confidence in the new COVID-19 shots.
The 25- to 30-second videos are real takes of real people—found online and then licensed with consent for the digital campaign, which launched last week on social media. Future plans include a move to local TV.
“Those are real people, real emotions and real scenarios,” Sharon J. Castillo, senior director of global media relations at Pfizer, said. “These are not actors. These were not staged. These are real. We are hoping that they remind all of us of the human touch that we crave so much of going back to normal and being able to hug our grandparents.”
With its tagline—“Science can make this possible. Only you can make it real.”—the campaign emphasizes that, while the arrival of COVID-19 vaccines is good news, it won’t make a difference if a majority of people don’t get them.
Though Pfizer and BioNTech have launched their own product, this unbranded educational effort is meant to raise awareness about all COVID-19 vaccines. The companies are working in conjunction with a broad group of trade associations that includes the American College of Emergency Physicians, American Nurses Association, National Black Nurses Association and the American Pharmacists Association.
Their goal? Quell the fear of the vaccine, especially in Black and Hispanic communities.
RELATED: Pfizer plans DTC effort to pitch COVID-19 shot safety, joining a fall flurry of vaccine messaging
A key part of that effort is dispelling the misconception—and fear—that the vaccines were rushed. As Castillo said, the campaign website and partner groups aim to let people know that there were no shortcuts or skipped steps, but rather an “unprecedented collaboration between what are usually competitors.”
“When it comes to vaccine confidence and making sure that people have the right information, we all have a role to play,” she said. “The industry has a role to play, academia, the media—I mean, we’re all in this together, and so the more of these that people see, the better.”
Issues have emerged and put in the public domain in some other countries – hopefully the MHRA will not take much longer…..
MHRA Customer Services
2:33 PM (5 hours ago)
Thank you for your email.
The MHRA are working in collaboration with partners in the health system to rapidly assess all available safety data in real time and communicate any emerging issues, as necessary.
To provide reassurance as to the ongoing benefit and risk assessment of available vaccines the MHRA intends to publish details of all suspected reactions reported in association with available COVID-19 vaccines, along with our assessment of the data on a regular basis. We have your contact information and to help assist we will send you a link to the ADR data report once it has been published.
You can be assured that we continue to adhere to the highest standards of safety with available COVID-19 vaccines.
MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU Telephone 020 3080 6000
A typical MHRA response! – I note the “once it has been published” in reference to the ADR data report! They’re keeping very quiet as yet about the report from Israel etc. aren’t they re :- care homes/ lack of Pfizer vaccine 2nd. dose, although BBC interviewing care home managers where deaths are occurring of residents who had the Pfizer vaccine in early December but had not been given a second dose. To quote “it’s spreading like wildfire through our care homes once more”. I thought the whole point of starting with the elderly and vulnerable was to keep more of them ALIVE? Another fine mess!
The Who has a massive bureaucracy – even more complications now UK has left EU but Now I get it -the leaking of discussions on vacc passports via BBC radio recently is preparing the way for UK to take them up. UK is out of the EU but surely a vacc tsar , Nadhim Zahawi was appointed as the minister responsible for its roll-out would know that The Who has already been busy on drawing up vacc passports. He avoided mentioning this even though he surely knows it will impact on UK
Home/Newsroom/Article/World Health Organization open call for nomination of experts to contribute to the Smart Vaccination Certificate technical specifications and standards – Application DEADLINE 14 December
(Any bureaurocracy which uses a ‘Secretariat’ sounds dodgy )
Bearing in mind – 2020 thousands of files after government agency refuses to pay ransom and peope are being subjected to faraudalent offers of tests and vaccines already https://www.techradar.com/news/stolen-covid-vaccine-data-may-have-been-manipulated-before-being-leaked-online
Tech companies are racing to build smart vaccine passports. But technology isn’t the only problem Vaccination card group includes Microsoft, Mayo, Epic, Oracle, and more
Chris Burns – Jan 14, 2021, 11:35am CST
A Vaccination Credential Initiative (VCI) was created for the near future in which COVID-19 vaccination checks are imperative. The VCI is a coalition of public and private partners that include Evernorth, Mitre, SAFE, SalesForce, Change Healthcare, CARIN, The Commons Project, Epic, Mayo Clinic, Oracle, and Microsoft. Cards will allow individuals to access and display their vaccination records “based on open, inoperable standards.”
By Daphne Leprince-Ringuet | January 21, 2021 — 10:11 GMT (10:11 GMT) | Topic: Digital Health and Wellness
As some countries around the world start vaccinating their populations against COVID-19, the idea of creating digital “vaccine passports” is gathering pace. Among those leading the way, the Estonian, Hungarian and Icelandic governments have all signed up to pilot a technology that would allow people who have received the jab to prove their health credentials at the scan of a QR code.
Dubbed VaccineGuard, the platform’s goal is to link between various agents, from the vaccine’s point of manufacture all the way to the border guard controlling an individual traveler, to create a system in which reliable information about the immunization process can be shared across myriad different sources and countries.
The code will act as a verified proof of vaccination that can be displayed when required – whether that is to travel, to go back to work or to attend a public event.
VaccineGuard is being piloted as part of an agreement signed between Estonia and the WHO
The company behind the platform, Guardtime, also announced a partnership with vaccine manufacturer AstraZeneca in Estonia, to further expand the scope of VaccineGuard’s data ecosystem. Using blockchain technology, vaccine manufacturers will be able to serialize the vials they produce, creating a birth certificate of sorts so that products can be tracked all the way to their point of administration.
The EU was recently reported to be looking at a common agreement on vaccination certificates;
(And what the vaccine tzar Nadhim Zahawi who was appointed as the minister responsible for the vaccine roll-out forgot to mention on ‘question time’ BBC1—)
and the UK has just started testing a “COVID-19 immunity and vaccination” passport, that would let patients who have been tested or vaccinated use a free app to prove their health status.
2nd Covid Vaccine should be 21 /28 Days NOT 12 Weeks: Challenge Government
276,801 have signed. Let’s get to 300,000!
This site is intended for health professionals only
Immunology and vaccines Doctor raises £20k to legally challenge second dose Covid vaccine delay
19 January 2021
A doctor is raising money to launch a legal challenge against the Government’s decision to extend the gap between Covid doses to 12 weeks, Pulse has learned.
They are campaigning for the Government to ‘stop gambling with the health’ of at-risk individuals including healthcare workers and allow second doses of the Pfizer vaccine to be given at 21 days.
It comes as the Government has refused to guarantee that everybody will get their second dose of the vaccine within 12 weeks.
The guidance changed on 31 December to say all second doses should be given after 12 weeks instead of three weeks to maximise the number of people protected in the shortest possible time frame.
Some GPs had decided to honour second-dose appointments already made but NHS England changed the enhanced service conditions to ban this practice as of Monday last week.
London paediatrician Dr Michael Markiewicz launched a crowdfunder earlier this month to take out an injunction against the Government to ‘stop them delaying giving the second dose of the Pfizer Covid vaccine’.
So far, the fundraiser has raised £23,479 of its £20,000 target.
The JustGiving page said: ‘This Government has decided that it knows better than the manufacturer of the vaccine. It says it makes its decisions based on science so I ask, show us the science (and don‘t extrapolate or massage data not specifically relevant).
‘If you can’t, then stop gambling with the health of all those who are considered at risk – such as the elderly, clinically extremely vulnerable and health workers – who were prioritised initially and for whom it would be essential to receive the second dose in the time recommended by the company to achieve full protection.’
Dr Markiewicz’ legal team has written twice to health secretary Matt Hancock, whose reply will ‘decide what further action we can take’, he said.
He told Pulse: ‘I was very upset that I could find no data about the fact that it was safe to delay the second dose. I asked Pfizer and the MHRA whether they had any data and I have not had a satisfactory answer to suggest that there is any data out there other than extrapolated data.
‘Eventually we may find that it is safe, but my first principle in medicine is do not do harm. How do we know we’re not harming the people who have had the first dose, the vaccine efficacy isn’t going to drop off and it doesn’t promote the introduction of new mutant viruses?’
He added: ‘You cannot base medicine on a political decision. Any treatment must have evidence or scientific data as its origin.’
Last week, Labour peer and former Government Voice of Older People Joan Bakewell also launched similar legal action to establish whether the Government policy is ‘lawful and safe’.
Dr Markiewicz told Pulse his legal team is meeting with that of Lady Bakewell, who has also raised almost £20,000, with a view to joining forces.
A petition also seeking to challenge the second dose delay has amassed more than 275,000 signatures.
A joint statement from Pfizer and BioNTech said: ‘The safety and efficacy of the vaccine has not been evaluated on different dosing schedules as the majority of trial participants received the second dose within the window specified in the study design.
‘There is no data to demonstrate that protection after the first dose is sustained after 21 days.’
We hear over and over again ‘lessons have been learned’ Too few are,
too often it’s more expedient to bury them along with all the untold thousands of dead bodies
This was written approx 10 yrs ago and uses the same devious gobbledigook as given to David H – it’s worth a read as we try to protect ourselves and others as best we can against the Covid viruses.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1447151/ A monstrous tale of anthrax vaccination
Just to say I am not %100 anti-vaccines but am %100 pro us all having the same information as the bureaucrats ,which enables them to make the best decisions possible for themselves and their own, We are simply continuing the farce of thinking we live in a mature democracy when we have to keep begging at the door for honest information.
The ‘sexed-up’ gamble …
…their advice in my view should be rejected.’
I fear ditching dose timetable could prove a costly mistake, writes immunology expert PROFESSOR HERB SEWELL
By PROFESSOR HERB SEWELL
PUBLISHED: 22:41, 21 January 2021 | UPDATED: 10:30, 22 January 2021
This would be more likely to happen in older people because the immune system changes as we age. It is concerning that this is exactly the group for whom the second dose is being delayed.
Most international medical bodies – the World Health Organisation, the Centre for Disease Control, the U.S. Food and Drug Administration – are saying the same thing: we must stick to the schedule defined by the manufacturers of the vaccines, Pfizer and Moderna.
Crucially, the makers never claimed a single jab would be enough. That decision has been made by politicians, who saw that the vaccine would be in short supply to begin with, and decided to spread it thinly.
This notion was heavily promoted by Tony Blair, the former prime minister who has been a major influence on Government policy during the pandemic. Scientists from his Tony Blair Institute advised Whitehall’s officers, quite erroneously, that a single dose would be efficacious. Unless they can produce scientific data to back up their claims, their advice in my view should be rejected.
The truth of the matter, at least here in the UK, I guess, is this :- in reply to so many questions, the answer given by scientists and government officials alike is “we don’t YET know”. Isn’t that really enough to convince us that we are all ‘guinea pigs’ in this major attack on the whole of our nation, whether it be from physical or mental ill health?
Anybody out there seen a copy of the letters? Can you take a lead regarding truth and transparency from DH ? (see Rxisk blog)MAke a principles action and let those who need to read them see them We all need to see them – no secrets is part of the GMC advice to doctors in so many words – No wonder they’re keeping quiet Mary…. So a bit late in the day the BMA (trades union for doctotrs ) and thebmj have both sent letters to Whitty and co. requesting that the waiting time beteen doses of vaccs be reduced – but not reinstated to comply with the pharma co.s accusation that UK is not complying with the trials results. imperfect as they are all other countries (and the WHO) are complying and are bewildered that the UK population is being potentially put at greater risk by the vaccine on top of the actual covid viruses by the reduction of interval times to 12 weeks instead of 2//3/ weeks – it is a worrying situation for those who have already been vaccinated or haven’t decided whether to take it.
It’s taken the BMA and thebmj too long before writing letters in a formal manner as welcome as they are – but we need to know why they are asking for a reduction in the interval between doses of 6weeks instead of 12 weeks – which is still in breach of the pharma co’s trials results. Is the pride of Whitty and co. a factor ? Is it because many but not all of those who have already vaccinated could be caught within 6 weeks but not as many in 2/3 weeks from date of vaccination?
Meanwhile could someone with a maths brain tell me if this makes sense ? How is the 99% arrived at. ? via letter being sent around Wales
‘These groups represent around 99% of preventable deaths from Covid -19
COPD; heart disease; kidney disease; liver disease; neurological disease; Downs syndrome; leanrning disability; diabetes; transplants; cancers. immunsuppression; splenic dysfunction; obesity ; severe mental illness.
Is it an average ? average of what if so ? the daftest thing I heard on some media prog was paraphrase – ‘the results are an average of a random sample’
What’s the point in a vaccine passport if the vaccine isn’t 100% protective and only lasts a couple of months?
I was shocked that people have to get £100 private test done 3 days before travel. Someone is making a lot of money out of this nonsense. You could catch covid within the three days after your test, so what’s the point in it?. Plus the test isn’t accurate either and doesn’t mean you have Covid even if you test positive.
As for the track and trace app so many people are either not downloading it or deleting it from their phones now because it’s stopping people from going to work every other week.
People will stop complying, it’s a full time job keeping up with it all.
What happens when the majority are unemployed and can no longer afford a phone contract? The app will be useless then anyway.
As for all these mutations well how many vaccines are we all expected to have in the future because each vaccine will only cover certain mutations and for only several months and isn’t gauranteed to stop you spreading it either.
What a mess the whole thing is.
Hopefully we will have a hot summer and it will burn itself out naturally.
potentially severe consequences, including nullifying vaccine efficacy.
Patrick D Hahn
A blatant violation of the principle of informed consent:
Revisiting the UK’s strategy for delaying the second dose of the Pfizer covid-19 vaccine –
Neutralising antibody immunity likely to fall with delayed dose, say these authors
Herb F Sewell, Emeritus Professor of Immunology and Consultant immunologist, University of Nottingham.
John FR Robertson, Professor of Surgery and Consultant Surgeon, University of Nottingham.
Marcia Stewart, Social Care professional and emeritus academic BA(Hons) De Montfort University.
Denise Kendrick, Professor of Primary Care Research and General Practitioner, University of Nottingham.
Sheila M Bird, formerly programme leader at the MRC Biostatistics Unit in Cambridge.
Revisiting the UK’s strategy for delaying the second dose of the Pfizer covid-19 vaccine
The peak after the first dose was modest and the fall in neutralising antibodies significant between days 15-21. Indeed, by 28 days, all participants’ Nab levels had fallen to very low levels. The second dose produced a larger secondary immune response which subsequently also decreased, although over a longer time period of a few months. This decrease was more pronounced in the participants in the 56-70 and 71+ years age groups and suggests that, in the older age, the duration of neutralizing antibodies from the Moderna vaccine will be shorter. This questions whether they will be sufficient to protect older citizens beyond a year. Given these are the age groups most at risk of severe covid-19, the data in the NEJM letter suggest that annual vaccination may be required. These data can reasonably be used to inform thinking about deferral of the Pfizer/BioNTech second dose as it is also a mRNA vaccine, this time with the second dose at 22 days.
These two are the first mRNA based vaccines to be used therapeutically in humans. The number of individuals who contributed to sequential testing of Nab response was small (at most 15 per age-group), so we recognise the limitations of these data. However, they are the most recent data available on Nab induction and duration in humans using mRNA vaccines. The UK, in particular, should be geared up to augment this evidence base. The marked decrease of Nab reported in all age groups at 29 days (i.e. at the time of 2nd dose) is a salutary point to note, given the UK’s strategy for deferral of the 2nd mRNA dose out to 85 days.
We recognise that Nab is only one contributory arm of protective immunity.  Nevertheless, the NEJM letter on a very similar mRNA vaccine to the Pfizer/BioNTech is of concern in respect of: i) the level of personal protection a single dose offers an individual (due to the marked fall in Nab before a second dose), so that extending to 12 weeks may increase infection-risk; ii) the challenge it poses for the undisclosed modelling that the UK government has relied upon to justify altering a proven efficacious standard two dose schedule; and iii) the risk it raises, from a population perspective, of enhancing virus “escape mutations” associated with suboptimal immunity, which could have potentially severe consequences, including nullifying vaccine efficacy. [9,10] A further concern is that these significant decreases in Nabs are despite the Moderna vaccine dose having a higher concentration of mRNA than the Pfizer dose (100ug versus 30ug respectively).
In our view, all of these reasons should make the government reconsider their strategy.
Why is the majority of medics not being more open about it?
Medical people are the cure to the problem. Do we continue to live in lockdown knowing a third of the population will become homeless and jobless because of lockdowns?
How many people are committing suicide because of the stress of their losses and dying from lack of other medical problems because of Covid?
Medics need to speak out about the truth of Covid lockdowns! If they truly want to save lives.
Always the same marginal people are the first to suffer the consiquences of government desicions. The poor mean nothing and are an acceptable loss/collatrole damage to the government.
I apologise for any spelling mistakes.
The only people happy with lockdowns are the ones fourloughed. Nearly 4 million people in the UK are unable to get government financial help because they are either self employed, zero contracted hrs or free lance employed. These people will lose income and homes because of lockdowns and lack of financial government support.
Who allowed zero contract hours in the first place?
‘Written privately’ ! about something which is killing people. Show us ALL the letter –
J L thinks doctors should have special access by dint of being doctors and fee paying members of the BMA. That last bit really stinks. Where’s the morality in his proposal…. The BBC has seen the letter – the bmj has seen the letter, the BMA has seen the letter’, the politicians and medical officers have seen the letter. many admin workers will have seen the letter and it’s contents whether allowable of not under their terms of empyment, many of that group will have shared info with members in their social circles – who wouldn’t want to protect them. They need to stop witholding information we all need to know and have the right to know The BBC is a public body – the BMJ is funded by the BMA which aren’t subject to freedom of info requests as incredibly they are deemed to be charities – but the B’BC is bound to reply to Freedom of Information Requests – will no doubt be fobbed off by the trick of asking for umpteen clarifications or delayed until it’s useless – as per previous experiences ,but will make one nevertheless on ‘What do they know’ website
..Re: Covid-19: Assess the effects of extending Pfizer vaccine dosing interval, expert urges; now “BMA has written privately to Whitty”til it’s useless
Re: Covid-19: Assess the effects of extending Pfizer vaccine dosing interval, expert urges Elisabeth Mahase. 372:doi 10.1136/bmj.n162
I urged the BMA to take a proactive stance on this controversial policy issue and it appears, my plea has not fallen on deaf ears as the BMA has now publicly highlighted the same by warning that the proposed 12 week dose interval “could reduce the effectiveness of the vaccine”.
Further it is said, “The BMA has written privately to Whitty to express its concern over the gap between doses. The letter, seen by the BBC, said the policy was ‘difficult to justify’ “; if the BBC has seen such private letter, it is now arguably in the public domain, so there’s no good reason to withhold its disclosure at least to BMA’s fee-paying members. Indeed, the issue at stake is very much a matter of public interest and the BMA must be fully transparent in its dealings with a statutorily appointed, Chief Medical Officer.
Given the highly time critical nature of this issue particularly as thousands of healthcare staff are likely to be waiting for their second-dose, if the JCVI/government fails to reverse their decision, then there are some urgent steps the BMA should consider without any hesitation; I would say, it is imperative that the BMA:
(1) joins as an interested party to the proposed legal challenge by Joan Bakewell, or
(2) on its own initiative, commence urgent judicial review proceedings against the government in the High Court alleging, among others, irrationality and perversity of such unilateral policy to extend dosing interval up to 12 weeks without safe scientific data to back such policy.
If the BMA does not take the above action, then it should be ready to give cogent reasons to its fee-paying members who could face real health & safety risks as a result of the current highly contentious dosing policy of the government.
Competing interests: See text; have written on this subject earlier
23 January 2021
BMA doses interval
25 January 2021
The BMA has written to the Government calling for ‘a dialogue’ about halving the gap between Pfizer vaccine doses to six weeks.
Official guidance changed on 31 December to say all second doses should be given after 12 weeks instead of three weeks to maximise the number of people protected against Covid-19 in the shortest possible timeframe.
Some GPs had decided to honour second-dose appointments already made but NHS England later said this was banned.
Speaking to Sky News over the weekend, BMA council chair Dr Chaand Nagpaul said the BMA has written to the chief medical officer (CMO) about the 12-week interval, asking him to ‘reconsider the decision’.
He called on the Government to ‘look at guidance from the World Health Organisation’ (WHO) and ‘take stock of the fact that no other nation in the world has adopted the 12-week delay like the UK’.
BMA GP Committee chair Dr Richard Vautrey added that the BMA wants ‘a dialogue’ and ‘proper scientific enquiry’ over the issue, using new data from the vaccination programme.
He also told Sky News: ‘We need to understand the data and we want a dialogue with the CMO around that to really fully understand what the situation is now and what level of protection one dose is giving to our patients and to the healthcare professionals.
‘Six weeks is what the WHO recommend – they’ve done an analysis of the initial Pfizer data and it’s what Pfizer would recommend as well, looking at the extrapolation of their own studies – but we’ve now got far more data than the trials have ever had to look at.’
He added: ‘It’s important that we have a proper scientific enquiry, we review the evidence and that we’re open to looking at that evidence and implementing it as best as we can.’
The BMA is ‘talking specifically about the Pfizer vaccine’, as the Oxford/AstraZeneca vaccine ‘has got approval from its manufacturer for a delay of up to 12 weeks’, Dr Nagpaul said.
The BMA has said that it ‘recognises’ the need to ‘protect as many people as possible as soon as possible’ but will be ‘pushing’ for second doses of the Pfizer vaccine ‘as close as possible to the original schedule’.
While there is ‘some evidence’ that a longer interval between doses of the Oxford vaccine ‘promotes a stronger immune response’, there is a ‘lack of data’ on the impact of increasing the gap between Pfizer doses beyond 42 days, it added.
However, any delay to the delivery of second doses ‘must be used to rapidly accelerate vaccination of all frontline healthcare workers’, the BMA said.
A Department of Health and Social Care spokesperson said its priority was to protect as many vulnerable people against coronavirus in the shortest possible time.
The spokesperson said: ‘The decision to change vaccine dosage intervals followed a thorough review of the data and was in line with the recommendations of the UK’s four chief medical officers.
‘Both vaccines provide a high degree of protection after the first dose, and the Government has closely followed the guidance of the Joint Committee on Vaccination and Immunisation (JCVI) which was clear that we should give as many people as possible some level of immunity initially.’
In the Government’s daily Covid-19 press briefing on Friday, England’s CMO, Professor Chris Whitty, was asked whether the 12-week interval between vaccine doses would reduce protection.
He said ‘the answer is slightly different’ for each of the two vaccine types being used in the UK.
He added: ‘But in both cases, we think that the great majority of the protection is given by the first vaccine and the second one is going to top that up and to extend it over time, but we do actually have confidence that there will be a lot of protection after the first vaccination.’
He said: ‘Now of course we’ll keep that under review as new data comes in.
‘But there are several lines of data that make us think it is likely that once you get protection, initially, it lasts for a reasonable period of time – including people who’ve had the natural infection where they seem to have protection for many months… and it also looks as if that’s the case with several different vaccine types which have been tried with one vaccine and then a later dose, later on.’
It comes as a doctor has raised more than £20,000 to launch a legal challenge against the Government’s decision to extend the gap between doses.
Meanwhile one in 10 GPs are yet to receive their first dose of the Covid vaccine.
Earlier this month, the BMA urgently called on the Government to ensure that GPs and practice staff are vaccinated by the end of January or ‘within two weeks’ if at high risk.
The Government has refused to guarantee that everybody will get their second dose of the vaccine within 12 weeks.
“Sad to say that I tested positive for Covid this week… symptoms started 2.5 weeks after my second Pfizer shot. Feeling a bit defeated and anxious about passing it on to my partner.
Grateful for a warm bed!
Hoping for some super immunity after all of this.”